The Complaint Determination Associate will work under the guidance of the Team Lead, Complaint Determination, who is a leader within Global Product Monitoring. This individual will execute a process to ensure compliant complaint determination decisions are made. This person is responsible for completing all aspects of the complaint determination process. They will follow established global regulations and processes for complaint determination.

Responsibilities

Review and execute the process to determine if an inquiry record meets the definition of a medical device complaint

Assign cases, determined to be complaints, with an appropriate category to allow for better assignment at the next phase of the complaint handling process

Assign cases, containing non-complaint feedback, with an appropriate category to allow for better trending and reporting activities

Reassess inquiry records when new information is received

Performs other complaint handling responsibilities as required

Required Leadership/Interpersonal Skills & Behaviors

Ability to handle team interpersonal conflicts and find an acceptable resolution

Proven experience to organize, prioritize and follow through on multiple tasks with minimal supervision

Ability to organize and judge priorities.

Strong attention to detail.

Ability to work in a team environment

Required Skills and Competencies

Demonstrated knowledge of Microsoft Office

Effective written and verbal communication skills

Ability to generate and maintain accurate records

Education and Experience

Work experience in a technical and/or quality/compliance discipline/regulated industry, with data management, record keeping, and technical aptitude